POMDRA Tool for Steam Sterilization

Download the assessment tool here. Following are instructions on how the assessment tool should be used:

For the registrant who uses a steam sterilizer to reprocess reusable semi-critical and/or critical medical devices: As a self -assessment tool. This self-reflective exercise is an opportunity for the registrant to identify deficiencies prior to participating in POMDRA. Once it has been completed by the registrant it does not need to be submitted to the College.

For the medical device reprocessing (MDR) assessor during an in-person visit: During an on-site assessment, the College MDR assessor will use this tool to assess the MDR practices of the office related to the office reusable medical devices and the steam sterilizer. Upon completing the tool, the MDR assessor will provide on-the-spot feedback based on the assessment results. The tool will also be the final report sent to the registrant for follow-up.

Common MDR Deficiencies for Steam Sterilization in Physician Offices

Inappropriate product is used to clean reusable medical devices during the cleaning step. The product must be a detergent and not a disinfectant product.

Re-useable cleaning accessories are not cleaned and sterilized between uses (or disposable cleaning accessories should be used and discarded daily).

Biological monitoring is not being performed.

Internal chemical indicators not being placed in each package for sterilization.

External chemical indicators not being placed on the outside of each package for sterilization.

Sterilization monitoring parameters (physical, chemical and biological) are not documented.

Inappropriate wrapping materials and tape used for packaging equipment for sterilization.

Personal protective equipment is either not available or not worn by staff when reprocessing.

The manufacturer’s instructions for reprocessing medical devices are not available.

Reprocessing is occurring in patient care areas with patients present.

Documented policies and procedures are not developed for all steps of reprocessing and training procedures for reprocessing staff.

Checklist for Purchasing a Tabletop Steam Sterilizer

The following document outlines specific criteria that should be considered before purchasing a new tabletop steam sterilizer: